EP1398048A1 - Durchflussbegrenzer mit Sicherheitsfunktion - Google Patents

Durchflussbegrenzer mit Sicherheitsfunktion Download PDF

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Publication number
EP1398048A1
EP1398048A1 EP20020388059 EP02388059A EP1398048A1 EP 1398048 A1 EP1398048 A1 EP 1398048A1 EP 20020388059 EP20020388059 EP 20020388059 EP 02388059 A EP02388059 A EP 02388059A EP 1398048 A1 EP1398048 A1 EP 1398048A1
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EP
European Patent Office
Prior art keywords
flow restrictor
flow
channel
portions
opposed
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP20020388059
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English (en)
French (fr)
Inventor
Per Elgard Pedersen
Henrik Bendsen
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Novo Nordisk AS
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Novo Nordisk AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novo Nordisk AS filed Critical Novo Nordisk AS
Priority to EP20020388059 priority Critical patent/EP1398048A1/de
Priority to EP03793604A priority patent/EP1545657B1/de
Priority to DE60309487T priority patent/DE60309487T2/de
Priority to AU2003258489A priority patent/AU2003258489A1/en
Priority to US10/657,611 priority patent/US20040116905A1/en
Priority to AT03793604T priority patent/ATE344071T1/de
Priority to PCT/DK2003/000574 priority patent/WO2004022136A2/en
Publication of EP1398048A1 publication Critical patent/EP1398048A1/de
Withdrawn legal-status Critical Current

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J19/00—Chemical, physical or physico-chemical processes in general; Their relevant apparatus
    • B01J19/0093—Microreactors, e.g. miniaturised or microfabricated reactors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/141—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor with capillaries for restricting fluid flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1454—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons spring-actuated, e.g. by a clockwork
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16877—Adjusting flow; Devices for setting a flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M2005/14513—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons with secondary fluid driving or regulating the infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
    • A61M2005/1652—Filter with duct, e.g. filtering element incorporated in a flow line, tube, duct
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
    • A61M5/1483—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags using flexible bags externally pressurised by fluid pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2219/00—Chemical, physical or physico-chemical processes in general; Their relevant apparatus
    • B01J2219/00781—Aspects relating to microreactors
    • B01J2219/00783—Laminate assemblies, i.e. the reactor comprising a stack of plates
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2219/00—Chemical, physical or physico-chemical processes in general; Their relevant apparatus
    • B01J2219/00781—Aspects relating to microreactors
    • B01J2219/00891—Feeding or evacuation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/08—Regulating or influencing the flow resistance
    • B01L2400/084—Passive control of flow resistance
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip

Definitions

  • the present invention relates to a flow restrictor suitable for the controlled transfer of fluid from a first compartment to a second compartment. More specifically, the invention relates to a safety arrangement reducing the risks associated with diminished flow resistance through the flow restrictor.
  • Such flow restrictors are suitable for the application in fluid delivery devices of the bleeding hole type, such devices being suitable in particular for the in situ administration of a therapeutic drug preparation over a prolonged period of time, however, such devices may also be used in areas such as biochemistry, microbiology and chemical analysis.
  • Diabetes mellitus is the common name for at least 2 different diseases, one characterised by immune system mediated specific pancreatic beta cell destruction (insulin dependent diabetes mellitus (IDDM) or type 1 diabetes), and another characterised by decreased insulin sensitivity (insulin resistance) and/or a functional defect in beta cell function (non-insulin dependent diabetes mellitus (NIDDM) or type 2 diabetes).
  • IDDM immune system mediated specific pancreatic beta cell destruction
  • insulin resistance insulin sensitivity
  • NIDDM non-insulin dependent diabetes mellitus
  • type 1 diabetes The principal treatment of type 1 diabetes is straight forward substitution of the missing insulin secretion, whereas treatment of type 2 is more complicated. More specifically, in early stages of type 2 diabetes treatment a number of different types of drugs can be used, e.g. drugs which increase insulin sensitivity (ciglitazones), decrease hepatic glucose output (e.g. metformin), or reduce glucose uptake from the gut (alfa glucosidase inhibitors), as well as drugs which stimulate beta cell activity (e.g. sulfonylurea/meglitinides).
  • beta cell stimulators will eventually fail to stimulate the cell, and the patient has to be treated with insulin, either as mono therapy, or in combination with oral medication in order to improve glucose control.
  • the first mode including syringes and insulin injection pens. These devices are simple to use and are relatively low in cost, but they require a needle stick at each injection, typically 3-4 times or more per day.
  • the second mode is infusion pump therapy, which entails the purchase of a relatively expensive pump, for which reason the initial cost of the pump is a barrier to this type of therapy.
  • the pump offer the advantages of continuous infusion of insulin, precision in dosing and optionally programmable delivery profiles and user actuated bolus infusions in connections with meals.
  • the infusion pump comprises means for allowing the contained insulin to be transferred to the body of the patient.
  • These means may take any desirable form providing the desired function, but presently pump arrangements comprising a conveying arrangement connected to the reservoir (i.e. an outlet to be associated with needle infusion means) and including a pressure or suction generating device for feeding the liquid contained in the reservoir by pressure or suction application from the reservoir to the body are preferred for transferring the insulin contained in the reservoir to the patient.
  • a number of different principles may be utilized, e.g.
  • osmotic pumps as known from for example US patents 4,340,048 and 4,552,561, piston pumps as known from for example US patent 5,858,001, membrane pumps as known from for example US patent 6,280,148, flow restrictor pumps (also known as bleeding hole pumps) as known from for example US patents 2,605,765 and 5,957,895, and gas generating pumps as known from for example US patent 5,527,288, which all in the last decades have been proposed for use in durable (refillable) and/or disposable (prefilled) drug infusion systems.
  • flow restrictor pumps also known as bleeding hole pumps
  • gas generating pumps as known from for example US patent 5,527,288, which all in the last decades have been proposed for use in durable (refillable) and/or disposable (prefilled) drug infusion systems.
  • these principles may not be considered to be pumps in the traditional sense, it may be more appropriate to generally describe these devices as delivery means for fluid, however, in the following description the traditional term pump will be used.
  • this principle provides a means for establishing a flow of a fluid at a desired rate by applying a force to a liquid to thereby force the liquid through a flow restrictor, the flow rate being determined by the applied force, the flow resistance in the flow restrictor and the viscosity of the fluid.
  • the drug to be infused is contained in a reservoir in fluid communication with an outlet through a flow restrictor.
  • actuating driving
  • the flow restrictor being provided by the through-going channel of a capillary tube
  • WO 02/15965 disclosing an infusion device in which the flow restrictor is in the form of a tortuous serpentine-formed channel established between two members.
  • the flow resistance is selectable just as a bolus function is provided.
  • US patent 5,993,414 discloses an infusion device utilizing a tortuous path flow restrictor.
  • an infusion device comprises a first cavity containing a drive fluid, a flow restrictor comprising a flow channel, a second cavity in fluid communication with the first cavity through the flow channel, and a drug reservoir containing the drug to be infused, where the second cavity and the drug reservoir is arranged such that the volume of the drug reservoir diminishes when the volume of the second cavity increases.
  • drive means for expelling the drive fluid from the first to the second cavity through the flow restrictor is provided, whereby drug is expelled from the drug reservoir.
  • the force-transmitting interface between the second cavity and the drug reservoir could be described as a secondary pump actuated by the drive means.
  • the drug flow rate will be determined by the applied force, the flow resistance in the flow restrictor and the viscosity of the drive fluid.
  • Advantages of the second variant are that the (delicate) drug does not have to be forced through the narrow flow restrictor and that a drive fluid having a high viscosity can be used thereby allowing a flow restrictor with a smaller flow resistance to be used which will normally be less expensive to manufacture. Examples of the second variant are disclosed in US patent 2,605,765 and German published patent application 25 52 446.
  • the bleeding hole principle thus has been proposed for a variety of drug infusion devices during the last five decades, it appears that the risks associated with this principle have until now not been properly identified. More specifically, the present inventors have realized that a pump based on the bleeding hole principle has a potential run-away risk if the flow restrictor is by-passed by alternative flow paths having a lower flow resistance, e.g. due to manufacturing errors or damage, which would result in the pump rate being too high which ultimately may result in drug overdosing.
  • a solution to this problem could be the provision of a flow sensor arranged close to the drug outlet and cooperating with alarm means, however, the provision of such additional systems would add considerably to the manufacturing costs, and be a major obstacle to the implementation of this pump principle for a prefilled, disposable infusion device.
  • Flow restrictors may be provided by many different structures, however, flow restrictors in which (i) a flow channel is established between two cooperating portions of at least two members, and (ii) a flow channel is provided in the form of a capillary tube, appear especially suitable for use in medical delivery devices due to there simple construction and well defined properties.
  • a given flow resistance may in principle be established by a narrow tubular channel of any desired length, however, a very short channel would have to be correspondingly narrow which would be difficult and expensive to manufacture. Therefore, a longer channel with a larger cross-sectional area is normally preferred, however, as this results in a relatively long channel it is necessary to "pack" the channel in an appropriate way, typically in a tortuous serpentine-like pattern comprising a plurality of U-formed portions arranged close to each other, see for example EP 1 177 802 and WO 02/15965.
  • the flow channel is established between at least two members, it is essential that these two members are held properly in place against each other, e.g. by bonding. However, in case of manufacturing imperfections or subsequent damage the close contact between the members may be incomplete such that fluid would flow in the gap between two adjacent members and consequently be able to short-circuit portions of the tortuous path resulting in a (considerably) lower flow resistance.
  • the present invention provides a flow restrictor comprising a flow-restricting channel (in the following generally described as a "flow channel") formed between at least a first member and a second member arranged in contact with each other, the flow channel being arranged to form at least one generally U-formed portion with a pair of opposed first and second channel portions, and with a safety channel arranged between the opposed first and second channel portions, the safety channel providing a fluid communication with an exterior space relative to the flow restrictor.
  • a flow restrictor of the invention may be formed integrally with the device in which it is implemented or it may be provided as a separate device or unit.
  • the safety channel establishes a flow path such that all or a portion of the fluid short-cutting the opposed channel portions in a given U-bend would be lead away from the flow channel, i.e. a "short-cut to the short-cut" is established.
  • the safety channel is provided with a low flow resistance ensuring that substantially all fluid leaving the regular flow path is lead away, however, the exact flow resistance which will ensure this will be dependent upon both the characteristics and nature of the flow restrictor as well as the characteristics of other components of the drug delivery system. In this way drug infusion will stop and overdosing will be prevented. Indeed, in case underdosing is an issue, appropriate flow detection and alarm means may be provided.
  • the flow channel as well as a plurality of safety channels is formed between two opposed surfaces.
  • a portion of a flow or safety channel is typically provided as an open trace or path formed in the surface of one member in combination with a planar portion of the other member which provides a "lid” thereby establishing a closed channel (indeed having one or two open ends).
  • the traces corresponding to different portions of the flow and safety channels may be provided in any of the two members in any desired configuration.
  • the flow channel as well as a plurality of safety channels is formed between an intermediate member sandwiched between two opposed surfaces.
  • through-going (i.e. perforating) traces are formed in the intermediate member, the through-going traces in combination with the opposed surface portions forming the flow channel and/or the safety channels.
  • the intermediate member is preferably relative thin (e.g. a foil) in order to provide a narrow channel, correspondingly, the safety channels may be formed from traces in one or both of the opposed surfaces in combination with the foil.
  • channels formed from two, three or more members may be incorporated in a single flow restrictor.
  • a fine capillary tube is used, the nature of which allows a relatively high flow resistance to be provided over a short length and at a low cost.
  • the capillary tube in most cases will be made from glass it is relatively fragile and it will be desirable to provide a supporting structure, however, in case a supporting structure (or any other structure) is provided surrounding the tube, a low resistance flow path may be established between the tube and the supporting structure, which in case of breakage of the fine tube may result in a dramatic reduction in flow resistance and a corresponding rise in the flow rate of the drive fluid.
  • the present invention provides a flow restrictor comprising a capillary tube having an outer surface and first and second end portions, a supporting structure supporting at least the first and second end portions, where the supporting structure is arranged such that a portion of the outer surface along substantially the entire length of the capillary tube is in fluid communication with an exterior space relative to the flow restrictor.
  • the supporting structure preferably supports the capillary tube at one or more points along the length thereof between the first and second end portions.
  • the supporting structure may be provided with inlet and outlet openings in communication with the respective ends of the capillary tube.
  • the supporting structure may comprise a safety channel in flow communication with the space surrounding the capillary tube, which channel may be in direct flow communication with the exterior space.
  • the exterior space relative to the flow restrictor may be represented by the "general space” surrounding an aggregate device in which the flow restrictor is incorporated or it may be an interior space in such a device. Indeed, in the latter case it should be prevented that any significant pressure builds up which would influence the function of the safety arrangement, e.g. by providing a relative large interior space or venting the interior space.
  • the present invention provides a delivery device comprising a first variable volume cavity containing a drive fluid, a flow restrictor as described above, a second variable volume cavity in fluid communication with the first variable volume cavity through the flow channel, a variable volume drug reservoir having in a situation of use an outlet, where the second variable volume cavity and the variable volume drug reservoir are arranged such that the volume of the drug reservoir diminishes when the volume of the second cavity increases.
  • the delivery device further comprises drive means for expelling the drive fluid from the first to the second cavity through the flow restrictor such that drug is expelled from the drug reservoir through the outlet.
  • the outlet means may be adapted to be brought in fluid communication with infusion means (e.g. a catheter tubing or transcutaneous access means such as an infusion needle, a flexible infusion cannula or a plurality of micro-penetrators) or may comprise these.
  • infusion means e.g. a catheter tubing or transcutaneous access means such as an infusion needle, a flexible infusion cannula or a plurality of micro-penetrators
  • infusion means e.g. a catheter tubing or transcutaneous access means such as an infusion needle, a flexible infusion cannula or a plurality of micro-penetrators
  • a delivery device of the above type may also be manufactured or offered to the user as a system in which individual components are combined with each other to provide an aggregate device.
  • a system comprising a disposable, pre-filled drug unit, a durable drive-force providing unit and a disposable unit comprising the drive fluid and the flow restrictor.
  • different flow restrictors providing different infusion rates in combination with a given drive-force could be offered.
  • the present invention provides a fluid transmitting device comprising a first variable volume cavity containing a drive fluid, a flow restrictor as discussed and described above, a second variable volume cavity in fluid communication with the first variable volume cavity through the flow channel.
  • drug is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension.
  • Representative drugs include pharmaceuticals such as peptides, proteins, and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
  • insulin refers to encompass any method of parenteral delivery to a subject.
  • Fig. 1A shows a schematic representation of a first embodiment of the invention.
  • the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.
  • a flow restrictor device 101 comprises an upper member 110 with a generally planar lower surface 111 (cannot be seen in fig. 1A) and a lower member 120 with a generally planar upper surface 121.
  • the upper member comprises first and second through-going bores 112, 113 serving as inlet respective outlet for the flow restrictor.
  • a flow trace 130 having an inlet end portion 131 and an outlet end portion 132 and a plurality of generally U-formed portions 135 each comprising a pair of opposed first and second "leg" portions 136, 137, the flow trace thereby forming a serpentine-like pattern.
  • the opposed portions may have any configuration (e.g. straight or curved) and may be arranged more or less in parallel with each other.
  • the trace 130 shown as a relatively broad structure, however, for most applications the trace will have a width and depth in the micrometer range.
  • safety traces 140 In the upper surface 121 between each of the opposed portions 136, 137 of the flow trace is formed safety traces 140 having a closed end 141 arranged in the vicinity of the closed end of the U and an opposed open end 142 in communication with the exterior. As schematically illustrated in fig. 1 is the cross-sectional area of the safety traces substantially larger than the flow trace.
  • the two members 110, 120 are attached (e.g. bonded) to each other with the opposed surfaces in mating contact, whereby the flow trace and the safety traces will be "closed” to form a flow channel respectively a plurality of safety channels, the flow channel having an inlet end portion in fluid communication with the inlet opening 112 and an outlet end portion in fluid communication with the outlet opening 113.
  • Fig. 1 B shows in part a schematic representation of a second embodiment of the invention.
  • the flow restrictor device 201 comprises an upper member 210 with a lower surface 211 and a lower member 220 with an upper surface 221, however, in the second embodiment an intermediate foil member 230 is sandwiched between the two opposed surfaces, the three members being bonded to form a laminate structure.
  • a through-going (i.e. perforating) trace 239 having essentially the same configuration as the trace 130 in the first embodiment.
  • the lower surface of the upper member is formed a plurality of safety traces 240 having essentially the same configuration as the safety traces 140 in the first embodiment. In this way a flow channel is formed between the three members in combination whereas the safety channels are formed between the first member and the intermediate member.
  • the flow restrictor device 301 comprises a capillary tube 330 mounted in a first support member 310.
  • the first support member 310 has a first surface 311 comprising a groove 320 adapted to accommodate the capillary tube.
  • the groove is slightly longer than the tube providing an inlet 321 and an outlet 322, and is configured to securely engage and support the tube at its end portions 331, 332.
  • corresponding to a narrow portion along its length the tube is supported on the lower surface 323 of the groove, just as two further supports 335 are provided however, corresponding to most of the surface of the tube, there is a clearance between tube and the support member.
  • the first support member further comprises two safety traces 336, 337.
  • FIG. 1D is the support member arranged against a second support member 340 whereby a support channel 320' is formed around the tube from which two safety channels 336' extend to the exterior.
  • the second support member 340 comprises two bores 341 arranged in flow communication with the inlet respectively the outlet.
  • Fig. 2A shows a schematic representation of an embodiment of the invention.
  • the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.
  • fig. 2A shows an infusion device 1 comprising a housing 10 and there from protruding actuation button 20.
  • the housing comprises an upper surface 2 and a lower surface 3 (not to be seen) adapted to be arranged against a skin surface of a user.
  • the upper surface is provided with a transparent window 4 allowing the user to view a drug reservoir arranged within the housing.
  • the infusion device has been arranged against the skin of a user and the actuation button has pressed into the housing by the user thereby actuating the infusion device as will be explained in detail below.
  • the housing comprises an upper wall 11, a lower planar base plate 12, side wall portions, an end wall 13 with an outer planar surface, and relative to the latter an opposed open end.
  • the housing comprises a first central wall 14 and a second oblique wall 15 in combination defining three compartments, a drive compartment 16, a reservoir compartment 17 and a needle compartment 18.
  • the drive compartment forms a flat cylinder with an open proximal end and a substantially closed distal end.
  • a piston 30 is slidingly arranged in the cylinder dividing the drive compartment in a distal fluid compartment 31 (corresponding to the above-described first cavity) filled with a viscous drive fluid (e.g.
  • the actuation button 20 comprises a skirt portion 21 slidingly received in the cylinder thereby closing the spring compartment.
  • the spring compartment are arranged two helical compression springs 33 acting on the piston, however, any compressible material or member providing a spring action or any other means providing or generating a force (e.g. gas generating means or a liquid/gas mixture) acting on the piston may be utilized.
  • the actuation button further comprises a wedge portion 22 to be received in the needle compartment.
  • the reservoir compartment comprises a flexible drug reservoir 40 with an insulin-containing drug formulation.
  • the reservoir is preferably manufactured from a transparent material allowing the user to view and control the drug through the window 4.
  • the reservoir In the initial state, i.e. before any drug has been expelled from the infusion device, the reservoir has a configuration substantially corresponding to the configuration of the reservoir compartment, thereby forming a neglectable cavity 19 (or dead-space) between the two components.
  • the space may be filled with a fluid (for illustrative purposes is the gap between the reservoir and the reservoir compartment relatively large).
  • the dead-space represents the above-described second cavity in a substantially fully collapsed state.
  • a U-formed membrane element 41 formed from a self-sealing material and comprising upper and lower membrane portions 42, 43.
  • an outlet opening 34 from the fluid compartment and an inlet opening 44 to the reservoir compartment is formed.
  • the infusion device further comprises a flow restrictor member 50 (see fig. 6) comprising a planer surface 51 in which a serpentine trace 52 is formed between proximal and distal end portions 53, 54. Between the opposed legs of the individual serpentine U-formed portions are arranged safety traces 59.
  • the flow restrictor member 50 is bonded to the outer planar surface of the housing end portion with the proximal and distal end portions in register with the outlet 34 respectively the inlet openings 44. In this way a flow restrictor channel with safety channels is formed between the two openings.
  • the resistance of the flow restrictor, the viscosity of the drive fluid and the force provided by the compressed springs will determine the rate at which the drive fluid will be forced through the flow restrictor to the reservoir compartment.
  • the infusion device further comprises a hollow subcutaneous infusion needle 60 as shown in fig. 7, comprising a distal pointed end 61 adapted to be introduced through a skin surface, a closed proximal end at which a needle wedge 62 is formed.
  • a needle wedge 62 is formed in the body of the needle.
  • an opening 63 is formed in flow communication with interior of the needle.
  • the proximal end of the needle is arranged in the needle compartment and with the needle body protruding through an opening 64 formed in the first wall 15 into the reservoir compartment and further into the reservoir.
  • the needle In the initial state (as supplied to the user and not shown in fig. 5) the needle penetrates the upper membrane portion 42 with the distal end 61 arranged between the upper and lower membrane portions 42, 43 inside the reservoir.
  • the user actuates the device by fully depressing the actuation button 20 until it locks in place in a recessed position (locking means arranged between the button and the housing is not shown in the figs.) whereby simultaneously the springs 33 are compressed and the wedge portion 22 is moved into the needle compartment.
  • the wedge portion comprises a lower oblique surface 23 in sliding contact with the needle wedge 62 whereby the wedge portion forces the needle downwardly as it is pressed into housing.
  • the pointed distal needle end 61 penetrates the lower membrane portion 43 and is forced out through an opening 65 formed in the base portion.
  • the infusion needle As the infusion device is attached to the skin surface of the user, the infusion needle is hereby introduced through the skin.
  • the needle opening 63 When the needle is in its fully extended position, the needle opening 63 is positioned between the two membrane portions whereby a fluid communication is established from the drug reservoir to the user.
  • the drive fluid starts to be expelled from the fluid compartment 31 and through the flow restrictor to the cavity portion 19 of the reservoir compartment 17 where it gradually will compress the flexible reservoir and thereby force out the therein contained insulin-containing drug through the needle and into the user.
  • the expelling means in form of springs 33 are "energized" during actuation of the device, however, to reduce the force needed to actuate the button 20 the spring means 33 may be pre-tensioned and the drive fluid 31 correspondingly pre-pressurized, whereby alone puncturing of the reservoir by the needle will actuate the expelling means and thereby start infusion.
EP20020388059 2002-09-09 2002-09-09 Durchflussbegrenzer mit Sicherheitsfunktion Withdrawn EP1398048A1 (de)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP20020388059 EP1398048A1 (de) 2002-09-09 2002-09-09 Durchflussbegrenzer mit Sicherheitsfunktion
EP03793604A EP1545657B1 (de) 2002-09-09 2003-09-08 Flussbeschränker mit sicherheitsmerkmal
DE60309487T DE60309487T2 (de) 2002-09-09 2003-09-08 Flussbeschränker mit sicherheitsmerkmal
AU2003258489A AU2003258489A1 (en) 2002-09-09 2003-09-08 Flow restrictor
US10/657,611 US20040116905A1 (en) 2002-09-09 2003-09-08 Flow restrictor with safety feature
AT03793604T ATE344071T1 (de) 2002-09-09 2003-09-08 Flussbeschränker mit sicherheitsmerkmal
PCT/DK2003/000574 WO2004022136A2 (en) 2002-09-09 2003-09-08 Flow restrictor

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20020388059 EP1398048A1 (de) 2002-09-09 2002-09-09 Durchflussbegrenzer mit Sicherheitsfunktion

Publications (1)

Publication Number Publication Date
EP1398048A1 true EP1398048A1 (de) 2004-03-17

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EP20020388059 Withdrawn EP1398048A1 (de) 2002-09-09 2002-09-09 Durchflussbegrenzer mit Sicherheitsfunktion

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EP (1) EP1398048A1 (de)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1957852A2 (de) * 2005-12-09 2008-08-20 Robert G. Schinazi Flussdrosselungsvorrichtung für eine medizinische vorrichtung
CN113730791A (zh) * 2016-02-22 2021-12-03 L2R企业有限责任公司 用于制造微流组合件的密封方法

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GB2049225A (en) * 1979-04-06 1980-12-17 Boc Ltd Fluid-flow restricting apparatus for mixing fluids
EP0110004A1 (de) * 1982-11-26 1984-06-13 Leybold Aktiengesellschaft Testleck
US4588319A (en) * 1984-10-25 1986-05-13 Nicolet Instrument Corporation Marking instrument
US4626244A (en) * 1985-02-01 1986-12-02 Consolidated Controls Corporation Implantable medication infusion device
US4662914A (en) * 1985-03-18 1987-05-05 Hewlett-Packard Company Flow-limited direct GC/MS interface
US4743235A (en) * 1986-09-05 1988-05-10 Medex, Inc. Flush control device
EP0344895A2 (de) * 1988-04-13 1989-12-06 Infusaid, Inc. Implantierbare Konstantdruckpumpe mit variablem Durchfluss
EP0410289A1 (de) * 1989-07-24 1991-01-30 Cosmo Instruments Co., Ltd. Mikroleckregulierventil
US5500071A (en) * 1994-10-19 1996-03-19 Hewlett-Packard Company Miniaturized planar columns in novel support media for liquid phase analysis
DE19548537A1 (de) * 1995-01-07 1996-07-11 Lang Volker Mikroinfusionssystem
US5603351A (en) * 1995-06-07 1997-02-18 David Sarnoff Research Center, Inc. Method and system for inhibiting cross-contamination in fluids of combinatorial chemistry device
DE29701416U1 (de) * 1997-01-28 1997-03-13 Fraunhofer Ges Forschung Dosiersystem
DE19825912C1 (de) * 1998-06-10 1999-05-27 Tricumed Medizintechnik Gmbh Implantierbare Infusionspumpe
US5935430A (en) * 1997-04-30 1999-08-10 Hewlett-Packard Company Structure for capturing express transient liquid phase during diffusion bonding of planar devices
EP0951916A2 (de) * 1998-04-23 1999-10-27 Medtronic, Inc. Implantierbare Medikamenteninfusionsvorrichtung
WO2001025138A1 (en) * 1999-10-04 2001-04-12 Nanostream, Inc. Modular microfluidic devices comprising sandwiched stencils

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2049225A (en) * 1979-04-06 1980-12-17 Boc Ltd Fluid-flow restricting apparatus for mixing fluids
EP0110004A1 (de) * 1982-11-26 1984-06-13 Leybold Aktiengesellschaft Testleck
US4588319A (en) * 1984-10-25 1986-05-13 Nicolet Instrument Corporation Marking instrument
US4626244A (en) * 1985-02-01 1986-12-02 Consolidated Controls Corporation Implantable medication infusion device
US4662914A (en) * 1985-03-18 1987-05-05 Hewlett-Packard Company Flow-limited direct GC/MS interface
US4743235A (en) * 1986-09-05 1988-05-10 Medex, Inc. Flush control device
EP0344895A2 (de) * 1988-04-13 1989-12-06 Infusaid, Inc. Implantierbare Konstantdruckpumpe mit variablem Durchfluss
EP0410289A1 (de) * 1989-07-24 1991-01-30 Cosmo Instruments Co., Ltd. Mikroleckregulierventil
US5500071A (en) * 1994-10-19 1996-03-19 Hewlett-Packard Company Miniaturized planar columns in novel support media for liquid phase analysis
DE19548537A1 (de) * 1995-01-07 1996-07-11 Lang Volker Mikroinfusionssystem
US5603351A (en) * 1995-06-07 1997-02-18 David Sarnoff Research Center, Inc. Method and system for inhibiting cross-contamination in fluids of combinatorial chemistry device
DE29701416U1 (de) * 1997-01-28 1997-03-13 Fraunhofer Ges Forschung Dosiersystem
US5935430A (en) * 1997-04-30 1999-08-10 Hewlett-Packard Company Structure for capturing express transient liquid phase during diffusion bonding of planar devices
EP0951916A2 (de) * 1998-04-23 1999-10-27 Medtronic, Inc. Implantierbare Medikamenteninfusionsvorrichtung
DE19825912C1 (de) * 1998-06-10 1999-05-27 Tricumed Medizintechnik Gmbh Implantierbare Infusionspumpe
WO2001025138A1 (en) * 1999-10-04 2001-04-12 Nanostream, Inc. Modular microfluidic devices comprising sandwiched stencils

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1957852A2 (de) * 2005-12-09 2008-08-20 Robert G. Schinazi Flussdrosselungsvorrichtung für eine medizinische vorrichtung
EP1957852A4 (de) * 2005-12-09 2012-05-16 Robert G Schinazi Flussdrosselungsvorrichtung für eine medizinische vorrichtung
CN113730791A (zh) * 2016-02-22 2021-12-03 L2R企业有限责任公司 用于制造微流组合件的密封方法

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